LAMOTRIGINE Drug Patent Profile
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Which patents cover Lamotrigine, and what generic alternatives are available?
Lamotrigine is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Ipca Labs, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa. and is included in fifty-one NDAs.
The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lamotrigine
A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.
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Questions you can ask:
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Summary for LAMOTRIGINE
| US Patents: | 0 |
| Applicants: | 40 |
| NDAs: | 51 |
| Finished Product Suppliers / Packagers: | 52 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 210 |
| Patent Applications: | 4,294 |
| Drug Prices: | Drug price information for LAMOTRIGINE |
| Drug Sales Revenues: | Drug sales revenues for LAMOTRIGINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMOTRIGINE |
| What excipients (inactive ingredients) are in LAMOTRIGINE? | LAMOTRIGINE excipients list |
| DailyMed Link: | LAMOTRIGINE at DailyMed |
See drug prices for LAMOTRIGINE
Recent Clinical Trials for LAMOTRIGINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mental Health Services in the Capital Region, Denmark | Phase 4 |
| Dr. Inge Winter | Phase 4 |
| Westfälische Wilhelms-Universität Münster | Phase 4 |
Pharmacology for LAMOTRIGINE
| Drug Class | Anti-epileptic Agent Mood Stabilizer |
| Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LAMOTRIGINE
Paragraph IV (Patent) Challenges for LAMOTRIGINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LAMICTAL XR | Extended-release Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | 022115 | 1 | 2014-02-12 |
| LAMICTAL ODT | Orally Disintegrating Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, and 200 mg | 022251 | 1 | 2009-12-21 |
US Patents and Regulatory Information for LAMOTRIGINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 078409-003 | Jan 22, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 206382-004 | Jun 17, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Torrent | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 203370-004 | Dec 23, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 201374-006 | Dec 26, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rubicon | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078625-003 | Jan 27, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
